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Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms

NCT ID: NCT01002274

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-06-30

Brief Summary

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This is an open-label extension study of another study protocol, MCS-2-TWN-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for this study.

Detailed Description

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This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the same daily dosage as the active treatment given under the protocol MCS-2-TWN-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.

Conditions

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Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Keywords

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Benign Prostatic Hyperplasia BPH MCS-2 Multi-Carotenoids Lower Urinary Tract Symptoms International prostate symptom score

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MCS-2

2 soft-gel capsules Qd for 40 weeks

Group Type EXPERIMENTAL

MCS-2

Intervention Type DRUG

2 soft-gel capsules Qd for 40 weeks

Interventions

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MCS-2

2 soft-gel capsules Qd for 40 weeks

Intervention Type DRUG

Other Intervention Names

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MUS

Eligibility Criteria

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Inclusion Criteria

* Subject has completed 12 weeks of treatment under the protocol MCS-2-TWN-a.
* Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.

Exclusion Criteria

* Subject has severe LUTS at the last visit under the protocol MCS-2-TWN-a.
* Subject is considered ineligible for the study by the investigator(s).
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Health Ever Bio-Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeong-Shiau Pu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MCS-2-TWN-c

Identifier Type: -

Identifier Source: org_study_id